Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
8 linked reportsInjury 8
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.8
2019-02
0
1.5
2019-03
0
1.5
2019-04
0
1.57
2019-05
0
1.5
2019-06
0
1.8
2019-07
0
1.43
2019-08
0
1.5
2019-09
0
1.56
2019-10
0
1.77
2019-11
0
1.17
2019-12
0
1.67
2020-01
0
1
2020-02
0
3
2020-03
0
2.7
2020-04
0
1
2020-05
0
1
2020-06
3
2.67
2020-07
0
3.75
2020-08
0
2.73
2020-09
0
1.67
2020-10
0
1.67
2020-11
0
3.11
2020-12
0
1.75
2021-01
0
1.86
2021-03
0
1.86
2021-04
0
1.67
2021-05
0
1.75
2021-06
0
3.33
2021-07
0
1.5
2021-08
0
2.5
2021-09
0
2.33
2021-10
0
2.5
2021-11
0
2
2021-12
0
2
2022-01
0
2
2022-02
0
2.14
2022-03
0
1
2022-04
0
1.5
2022-05
0
1
2022-06
0
4
2022-07
0
1
2022-08
0
2.75
2022-09
0
1.5
2022-10
0
2.5
2022-11
0
1.8
2023-01
0
4.5
2023-02
0
3
2023-03
0
2
2023-04
0
1
2023-05
0
3
2023-06
3
2
2023-07
0
2.67
2023-08
0
1.67
2023-10
0
2
2023-11
0
2.71
2023-12
0
1
2024-01
0
2
2024-02
0
2
2024-03
0
1.67
2024-04
0
2
2024-05
0
2
2024-06
0
2
2024-08
0
1
2024-09
0
1.75
2024-10
0
1.83
2024-11
0
2
2024-12
0
1.5
2025-01
2
2
2025-02
0
1.6
2025-03
0
1.5
2025-04
0
2
2025-05
0
2
2025-06
0
2
2025-07
0
1.5
2025-08
0
1.5
2025-09
0
1.67
2025-10
0
2
2025-11
0
2.22
2025-12
0
2
2026-01
0
1
2026-02
0
1.5
2026-03
0
2
2026-04
0
1.67
2026-05
0
1.5
2026-06
0
2
This device (reports/month)Average device in KRR (reports/device/month)
Failure-mode summaryAI-generated
8 linked report narratives available — no AI summary generated yet.
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
Date
Type
Outcome
Facility
Citations
2025-01-27
NAI
No action indicated
Integrity Orthopaedics Inc
0
2023-05-03
NAI
No action indicated
CARTIHEAL, LTD
0
2021-12-09
VAI
Voluntary action indicated
Smith & Nephew, Inc.
1
2021-12-09
VAI
Voluntary action indicated
Smith & Nephew, Inc.
1
2021-10-26
NAI
No action indicated
Smith & Nephew Inc.
0
2021-10-26
NAI
No action indicated
Smith & Nephew Inc.
0
2020-02-06
VAI
Voluntary action indicated
Blue Belt Technologies, Inc
6
2019-10-25
NAI
No action indicated
Tusker Medical, Inc.
0
2019-10-08
VAI
Voluntary action indicated
Tusker Medical, Inc.
3
2018-03-30
NAI
No action indicated
Ascension Orthopedics, Inc
0
2018-02-02
NAI
No action indicated
Smith & Nephew, Inc.
0
2018-02-02
NAI
No action indicated
Smith & Nephew, Inc.
0
2018-01-30
NAI
No action indicated
Smith & Nephew
0
2017-08-21
NAI
No action indicated
Smith & Nephew, Inc. Advanced Surgical Devices Division